Dosing Study of Amino Acids in Seriously Ill Patients
- Conditions
- Parenteral Nutrition (No Primary Condition Studied)
- Interventions
- Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection
- Registration Number
- NCT01923480
- Lead Sponsor
- Baxter Healthcare Corporation
- Brief Summary
The purpose of this study is to determine the best rate of infusion of amino acids (15% CLINISOL - sulfite-free (Amino Acid) Injection) for nutrition in subjects with with stages II to IVB head and neck cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
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Have Stages II to IVB head and neck cancer receiving radiation and may also be receiving chemotherapy.
* Subjects are eligible for inclusion in the study regardless of primary Stages II to IVB head and neck cancer treatment modality (eg, surgery, chemotherapy).
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Have voluntarily signed and dated a written informed consent form (ICF) after the nature of the study was explained to them.
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Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or;
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Female subjects of childbearing potential must be using adequate contraception (practicing 1 of the following methods of birth control):
- total abstinence from sexual intercourse (minimum of 1 complete menstrual cycle before study entry),
- a vasectomized partner,
- contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to study drug administration,
- intrauterine device (IUD), or
- double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
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Female subjects must have a negative serum or urinary pregnancy test result at screening (serum specimen must be obtained within 14 days prior to baseline).
- Had a loss of > 10% of body weight within the 3 month period prior to the study as noted in the subjects medical history chart.
- Have renal disease as determined by an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2.
- Have a hemoglobin level of < 9 g/dl.
- Have Stage 0, I, or IVC metastatic cancer.
- Have diabetes.
- Have any reason which, in the opinion of the Investigator, would prevent the subject from safely participating in the study.
- Have, in the opinion of the Investigator, a dependence on alcohol.
- Have, in the opinion of the Investigator, a dependence on illicit drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 15% CLINISOL 0.04 g/kg/hr 15% CLINISOL - Sulfite-free (Amino Acid) Injection 15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection. 15% CLINISOL 0.08 g/kg/hr 15% CLINISOL - Sulfite-free (Amino Acid) Injection 15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection. 15% CLINISOL 0.13 g/kg/hr 15% CLINISOL - Sulfite-free (Amino Acid) Injection 15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
- Primary Outcome Measures
Name Time Method Change in Net Protein Synthesis One time at pre-clinisol infusion and one time at post-clinisol infusion
- Secondary Outcome Measures
Name Time Method Plasma Concentration of Aspartic Acid Three times during each 7 hour visit Insulin Sensitivity Five times during each 7 hour visit Plasma Concentration of Glucose Nine times during each 7 hour visit Serum Concentration of Insulin Five times during each 7 hour visit Plasma Stable Isotope Enrichment of Phenylalanine Twelve times during each 7 hour visit Plasma Stable Isotope Enrichment of Tyrosine Twelve times during each 7 hour visit Plasma Concentration of Alanine Three times during each 7 hour visit Plasma Concentration of Arginine Three times during each 7 hour visit Plasma Concentration of Glutamic Acid Three times during each 7 hour visit Plasma Concentration of Glutamine Three times during each 7 hour visit Plasma Concentration of Glycine Three times during each 7 hour visit Plasma Concentration of Histidine Three times during each 7 hour visit Plasma Concentration of Isoleucine Three times during each 7 hour visit Plasma Concentration of Leucine Three times during each 7 hour visit Plasma Concentration of Lysine Three times during each 7 hour visit Plasma Concentration of Methionine Three times during each 7 hour visit Plasma Concentration of Ornithine Three times during each 7 hour visit Plasma Concentration of Phenylalanine Three times during each 7 hour visit Plasma Concentration of Proline Three times during each 7 hour visit Plasma Concentration of Serine Three times during each 7 hour visit Plasma Concentration of Taurine Three times during each 7 hour visit Plasma Concentration of Threonine Three times during each 7 hour visit Plasma Concentration of Tyrosine Three times during each 7 hour visit Plasma Concentration of Valine Three times during each 7 hour visit
Trial Locations
- Locations (2)
Texas A&M University, Center for Translational Research in Aging & Longevity
🇺🇸College Station, Texas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States